Sunshine Heart gets FDA tick for C-Pulse trial

Sunshine Heart (ASX:SHC) has secured unconditional approval from the US FDA to launch a pivotal North American trial of its C-Pulse Heart Assist Systems.

The company plans to commence the trial in the current quarter, and expects enrolment to take around two and a half years.

The study will involve 388 patients, of which half will be implanted with C-Pulse, while the other half will be randomised to optimal medical therapy.

Its primary endpoint will be reduction in worsening heart failure events leading to hospitalisation, mortality or the requirement to progress to advanced heart failure therapies. A one year safety follow up will likely follow.

Sunshine Heart CEO Dave Rosa said the company is “excited to evaluate the C-Pulse System's potential in treating patients suffering from Class III and ambulatory Class IV heart failure.”

C-Pulse is a is an implantable heart assist therapy for moderate to severe heart failure. It is designed to assist the left ventricle in pumping blood through the body, while increasing blood flow to coronary arteries.

The device is implanted through a procedure similar to the installation of a pacemaker, and sits outside of the bloodstream, reducing the risk of complications.

Sunshine Heart has CE Mark approval for the device in Europe, and last month secured conditional approval for an investigational device exemption (IDE) in the US.

Sunshine Heart (ASX:SHC) shares jumped by 25% on the back of the news in morning trading, but have dropped back to 3.2c, up 7% for the day, as of around 3pm Wednesday afternoon.